Laryngopharyngeal RefluxNCT01857713
Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device
A study testing Reza Band UES Assist Device in people with Laryngopharyngeal Reflux, run by Somna Therapeutics, L.L.C. at 5 sites in United States.
Trial summary
The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laryngopharyngeal Reflux
- What is being tested?
- Reza Band UES Assist Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year of age or older
- The patient must be willing and able to provide informed consent.
- Understands the clinical study requirements and is able to comply with follow-up schedule.
- Clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing)
- Reflux Symptom Index (RSI) >13
Who cannot join
- Currently being treated with another investigational medical device and/or drug
- Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
- The patient is female and is of child bearing potential and is not using an acceptable method of birth control, or is pregnant or breast feeding.
- Previous head or neck surgery or radiation
- Carotid artery disease, thyroid disease, or history of cerebral vascular disease
- Suspected esophageal cancer
Show all 9Show fewer
- Has either a pacemaker or implanted cardioverter defibrillator (ICD)
- Nasopharyngeal cancer
- Previously undergone Nissen Fundoplication
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Vanderbilt University
Nashville, Tennessee, 37212
Dr. Alan Raymond
New York, New York, 10016
Madison ENT & Facial Plastic surgery
New York, New York, 10016
Aurora Health Care
Summit, Wisconsin, 50366
About this study
Official title: A Multi-Center, Non-Randomized, Prospective Study of the Reza Band™ Upper Esophageal Sphincter (UES) Assist Device for the Treatment of Esophagopharyngeal Reflux
The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
Read the detailed description
The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing). Reza Band is to be worn when sleeping. The patient will put the Reza Band on at bedtime and take it off upon waking.
This is a prospective, non-randomized, open label, multicenter study designed to assess the safety and effectiveness of the Reza Band. At up to 5 investigational sites, up to 100 subjects will be enrolled.
The primary effectiveness endpoint is to be evaluated by the Reflux Symptom Index (RSI). Success is defined as >25% reduction in the RSI at the last follow-up, as compared to the baseline RSI. The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45.
All adverse reactions being reported will be evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band. Since some subjects may report the same event several times (e.g., redness), the first occurrence of the worst reported case of the event will be used for the purpose of analysis.
The incidence of site reactions, including laryngospasm, choking, pain, cough and hoarseness will be summarized. Exact 95% confidence intervals for the incidence rate of site reactions will be presented.
- Conditions
- Laryngopharyngeal Reflux
- Being tested
- Reza Band UES Assist Device
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reza Band UES Assist DeviceDevice
Device is worn by patient to reduce or eliminate laryngopharyngeal reflux
| Study group | Role | What they receive |
|---|---|---|
| Reza Band UES Assist Device | Active comparator | Patient is own control. Compare baseline to last follow-up after using device Receives: Device: Reza Band UES Assist Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks
The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).
Measured: 4 Weeks minus Baseline
Primary Safety
Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.
Measured: 4 Week Follow-up
Secondary outcomes (2)
SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 4 Weeks minus Baseline
Functional Outcomes of Sleep Questionnaire (FOSQ)
The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons.
Measured: 4 Weeks minus Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laryngopharyngeal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somna Therapeutics, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857713
- Sponsor's protocol ID
- RB-001-02
- Status last verified
- May 2015
- First submitted
- 16 May 2013
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Non-Randomized, Prospective Study of the Reza Band™ Upper Esophageal Sphincter (UES) Assist Device for the Treatment of Esophagopharyngeal Reflux
- ClinicalTrials.gov ID
- NCT01857713
- Acronym / sponsor ID
- RB-001-02
- Conditions
- Laryngopharyngeal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Somna Therapeutics, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Posted 21 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
Detailed description
The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing). Reza Band is to be worn when sleeping. The patient will put the Reza Band on at bedtime and take it off upon waking.
This is a prospective, non-randomized, open label, multicenter study designed to assess the safety and effectiveness of the Reza Band. At up to 5 investigational sites, up to 100 subjects will be enrolled.
The primary effectiveness endpoint is to be evaluated by the Reflux Symptom Index (RSI). Success is defined as >25% reduction in the RSI at the last follow-up, as compared to the baseline RSI. The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45.
All adverse reactions being reported will be evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band. Since some subjects may report the same event several times (e.g., redness), the first occurrence of the worst reported case of the event will be used for the purpose of analysis.
The incidence of site reactions, including laryngospasm, choking, pain, cough and hoarseness will be summarized. Exact 95% confidence intervals for the incidence rate of site reactions will be presented.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reza Band UES Assist Device | Active comparator | Device: Reza Band UES Assist DevicePatient is own control. Compare baseline to last follow-up after using device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 year of age or older
- The patient must be willing and able to provide informed consent.
- Understands the clinical study requirements and is able to comply with follow-up schedule.
- Clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing)
- Reflux Symptom Index (RSI) >13
Key exclusion criteria (9 listed)
- Currently being treated with another investigational medical device and/or drug
- Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
- The patient is female and is of child bearing potential and is not using an acceptable method of birth control, or is pregnant or breast feeding.
- Previous head or neck surgery or radiation
- Carotid artery disease, thyroid disease, or history of cerebral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reza Band UES Assist DeviceDevice is worn by patient to reduce or eliminate laryngopharyngeal reflux | Device | Reza Band UES Assist Device |
Primary outcome
Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks
Time frame: 4 Weeks minus Baseline
The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).
Primary Safety
Time frame: 4 Week Follow-up
Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.
2 secondary outcomes
SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score
Time frame: 4 Weeks minus Baseline
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 4 Weeks minus Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reza Band UES Assist Device in people with Laryngopharyngeal Reflux, run by Somna Therapeutics, L.L.C. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks (time frame: 4 Weeks minus Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.